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Falsification of Drug Records a Failure of the System Claims Expert

The criminal charges filed against a researcher last week for falsifying records on 21 drug studies is a symptom of a much bigger problem in the drug industry.

SANTA BARBARA, CA, January 19, 2010 /24-7PressRelease/ -- The criminal charges filed against anesthesiologist Scott Reuben last week for falsifying records on 21 drug studies is a symptom of a much bigger problem, claims legal expert, Terence Mix. The involved researcher from Baystate Medical Center in Springfield, Massachusetts is accused of falsifying records on studies that never took place. The drugs involved in the fictional studies included Merck's Vioxx and Pfizer's Celebrex and Bextra, each a member of the COX2 Inhibitor class of drugs used to treat pain suffered by orthopedic patients.

"Merck and Pfizer provided Reuben with grants to conduct studies on their drugs and he supplied both drug companies with the results they wanted to hear," says Mix. "He then had them published." Mix points out that consistent with the custom and practice of the industry, copies of these fabricated records would have been sent to the drug companies that supplied funding for the studies. "I would pose the following questions to both companies: Why didn't you discover the fraud and how closely did you scrutinize those records?"

Mix is not only critical of the involved drug companies, but points to the fact that this deception escaped detection for 12 years by Baystate Medical Center, where the studies were allegedly conducted, and the peer-reviewed journals where they were published. "These studies were published between 1996 and 2008, before improprieties were discovered during a routine audit by Baystate in May 2008," says Mix. "Someone at Baystate was asleep at the wheel for well over a decade. These were fictional studies allegedly occurring at the Baystate hospital, each of which required approval by its review board. The fact that it is also a research hospital in which about 200 studies a year take place should have increased its responsibilities. Each of the 21 studies should have been carefully monitored by the hospital, as they purportedly involved their own patients," he adds.

The journals in which the studies were published must also shoulder some responsibility, asserts Mix. He argues that one of the publications, "Anesthesia and Analgesia," carried 11 of the twenty-one papers and its editorial staff should have wondered why Reuben and his co-authors always wrote glowingly about the drugs they were allegedly studying. "In fact, they have admitted as much," says Mix, "when they recently acknowledged that Reuben's consistently favorable studies should have been a 'red flag' that something was amiss."

"This story exposes deficiencies and failures in the whole system of the postmarket testing of drugs," explains Mix. "None of these studies involved oversight by the FDA, even though drugs were being tested for several treatment regimens that had not been approved by that agency. And although off-label uses are allowed by physicians, a study funded by a drug company to justify expanding its approved indications should have been submitted for scrutiny by the FDA." Mix adds that the promotion of off-label uses by drug companies has been a major problem for years. He reminds that last year Pfizer paid a record $2.3 billion fine and two of its sales managers convicted for promoting and marketing the off-label use of the company's drug, Bextra, which was one of the drugs included in Reuben's fabricated studies.

"The whole system is in need of a major repair job," says Mix, "and the sooner it happens, the sooner we can start saving lives and reducing health care costs." He states that his forthcoming book, "The American Guinea Pig," will not only detail all of the multiple problems with the current system, but lay out a plan on how they can be eliminated. "The purpose of the book," he says, "is to re-establish the FDA as an efficient, responsible and accountable agency devoted to the public it was created to serve, rather than the drug industry it is purportedly policing."

Terence Mix is an attorney/author who writes about reform of the FDA and drug industry. For additional information, please contact him at (805) 681-1401 or (805) 452-6643.

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